Meta-analysis in Post-marketing Surveillances for SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT02284269
- Lead Sponsor
- Pharmaceuticals and Medical Devices Agency, Japan
- Brief Summary
The purpose of this study is to integrate the post-marketing surveillances data (Specified use-results surveys on long-term treatment) of the 6 SGLT2 inhibitors approved or applied in Japan and to evaluate the safety and efficacy of long-term use of each under actual clinical practice conditions.
In each post-marketing surveillance, 3000 patients who complete a 3 years treatment are enrolled. A total of 18000 patients are assessed in the meta-analysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 18000
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse events up to 3 years
- Secondary Outcome Measures
Name Time Method Incidence of cardiovascular events up to 3 years The change from baseline in vital signs and laboratory data Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration Incidence of cancer up to 3 years Incidence of other adverse events up to 3 years Incidence of drug-related adverse events up to 3 years Incidence of serious adverse events up to 3 years The change from baseline in HbA1c Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration The change from baseline in Fasting Plasma Glucose Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration